Borderline cosmetics: criteria for distinguishing them from medical devices and medicinal products in Italy

published on 3 September 2024 | reading time approx. 6 minutes

The use of the latest generation of cosmetics has made the line of demarcation between cosmetics, medical devices and medicinal products much more blurred. Research into nanotechnology, DNA and stem cells has highlighted possible problems with health and consumer information. These technologies and scientific advances lead to products that are difficult to classify into existing legal categories. Moreover, marketing strategies - such as the creation of the neologism ‘cosmeceuticals’ - further blur the line between the various categories.

Companies in the sector must, therefore, pay particular attention to the correct classification of their products. Otherwise, they risk significant penalties. Our mission as industry experts is to guide these companies through the complex landscape of regulations and classification criteria. Thanks to our experience and expertise, we can recognize these issues and take the right steps for correct product classification. This article is intended to support companies in this crucial process, ensuring that their operations comply with regulations and that consumers receive accurate and safe information.

Cosmetics, medical devices and medicinal products: definitions

The definitions of cosmetics, medical devices and medicinal products are a starting point for correctly classifying a product according to European legislation. These definitions are in fact harmonized: this means that they are the same within all member States because they are dictated by EU rules. This not only facilitates the movement of goods within the European Union, but also simplifies the work of companies, which thus do not have to provide a different classification for each Member State. These definitions make it possible to draw a first line between cosmetics, medical devices and medicinal products.

Cosmetics are regulated by Regulation (EC) 1223/2009 (also known as ‘Cosmetics Regulation’), which provides a broad definition. According to Article 2(1)(a) of the Regulation, a cosmetic product is ‘any substance or mixture intended to be applied to the external surfaces of the human body or to the teeth and the mucous membranes of the mouth with the sole or predominant purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.

Medical devices, on the other hand, include products - such as instruments, apparatus, equipment, software - intended to be used on humans alone or in combination for the medical purposes set out in Article 2(1) of Regulation (EU) 2017/745 such as the diagnosis of diseases, the monitoring and alleviation of injuries, and the study of anatomy or physiological or pathological processes or states.

Medicinal products may be defined according to their presentation or function: in the former case, they consist of a substance or combination of substances ‘presented as having properties for treating or prophylactically treating human disease’ (Art.1, par.1, letter a), no. 1, legislative decree no. 219 of 24 April 2006); in the second case, on the other hand, they consist of a substance or a combination of substances ‘that can be used on or administered to human beings with a view to restoring, correcting or modifying physiological functions, exerting a pharmacological, immunological or metabolic action, or to establishing a medical diagnosis’ (Art.1, par.1, letter a), no. 2, legislative decree no. 219 of 24 April 2006).

The line of demarcation between cosmetics, medical devices and medicines according to European Commission guidelines

For the purpose of facilitating the work of companies with regard to the correct legal classification of a borderline product, the European Commission has published guidelines on the scope of application of the Cosmetics Regulation that offer useful reference points for the classification process. Since borderline products cannot be immediately allocated to a specific category or sector, it can be difficult to identify the legislation applicable to them.

According to the working group on cosmetic products, the key element to be considered when classifying a borderline product is its intended use. A product that has cosmetic purposes and functions can only be classified and marketed as a cosmetic if the claims and wording on the label and in advertising are in line with the definition of a ‘cosmetic product’ and if they do not attribute characteristics to the product that it does not possess and cannot possess on the basis of the applicable legislation. In order to be able to correctly classify a product, it must therefore be assessed in its entirety, not only by looking at its formulation and its effects, but also by taking into consideration the aspects that have the greatest impact on its perception by the consumer (see advertising claims).

The correct classification of a product as a cosmetic, medical device or medicine is fundamental because the application of one of the regulations in question excludes that of the others: in fact, it is not possible for a product to fall under the scope of two different regulations at the same time. Article 1(6)(a) of Regulation (EU) 2017/745 (Medical Device Regulation) explicitly excludes the application of the Medical Device Regulation to cosmetics. A remarkably analogous is provided for in Article 2 of Directive 2001/83/EC, according to which, in the event of doubt as to the correct classification of a borderline product that could fall both under the definition of ‘medicinal product’ and that of a product governed by other legislation, the provisions on medicinal products apply. This provision is an expression of the so-called ‘principle of non-cumulation’, which is based on the Upjohn judgment of the EU-Court of Justice (Upjohn Company and Upjohn NV v Farzoo Inc. and J. Kortmann, C-112/89). According to the guidelines on the demarcation between Directive 76/768 on cosmetic products (later repealed and replaced by Regulation (EC) 1223/2009) and Directive 2001/83 on medicinal products, however, this principle only applies if it is clear that a product could fall within the definition of cosmetic and medicinal product at the same time.

The Impact of Borderline Products on Businesses

Quite often, the correct classification of a product as a cosmetic, medical device or medicinal product is not straightforward: companies have to make a case-by-case assessment that starts from the basics, i.e. from the definitions provided by EU law, and then assesses the product as a whole, taking into consideration all its characteristics, from the ingredients used in the formulation to the indications on the packaging or in the advertising, passing through the use for which the product is intended. In making such assessments, it is always advisable to refer to the guidelines published by the European Commission, designed to support companies in making the correct classification choice to avoid any detrimental consequences.

Incorrect product classification may, in fact, entail the risk of significant administrative and, in some cases, criminal penalties. In Italy, for example, anyone who, except in cases where it is expressly provided for and permitted by law, puts a medical device on the market without the CE marking, thus making the consumer believe that a different regulation applies to the product, such as, for example, the Cosmetics Regulation, risks being subject to an administrative sanction of up to 145,000 euros (Art. 27 co.22 of Legislative Decree 137 of 5 August 2022). If, on the other hand, a product is placed on the market and classified as a cosmetic when in fact it is a drug for which no authorization by the Italian Drug Agency has been issued, there is the risks of being imprisoned for up to one year and fined between EUR 2,000 and EUR 10,000 (Art. 147, par. 2 of Legislative Decree no. 219 of 24 April 2006); furthermore, the Italian Drug Agency may order the immediate withdrawal of the product from the market (Art. 144, par. 1 of Legislative Decree no. 219 of 24 April 2006).